Medical Device Accessories

Forms and Documents

Document Name	Status
0823_Supporting Statement_2019.doc Supporting Statement A	2019-08-21

IC Document Collections

IC ID	Document Title	Status
221835	Accessory classification de novo request Other-Guidance; Medical Device Accessories – Describing Accessor	Modified

ICR Details

OMB Control No: 0910-0823	ICR Reference No: 201908-0910-010
Status: Active	Previous ICR Reference No: 201606-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Accessories
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/24/2019
	Date Received in OIRA: 08/21/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved	09/30/2019
Responses	25	0	8
Time Burden (Hours)	1,000	0	1,440
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance document “Medical Device Accessories--Describing Accessories and Classification Mechanisms for Accessory Types” encourages manufacturers and other parties to utilize the “de novo request” process defined in section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of medical device accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. Under the de novo request process, manufacturers and other parties may submit a de novo requesting that FDA make a classification determination for the accessory device. The de novo must include a description of the device and detailed information and reasons for any recommended classification.

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Authorizing Statute(s): US Code: 21 USC 321 Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 13296	04/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 40067	08/13/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Accessory classification de novo request

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	25	8	0	0	17	0
Annual Time Burden (Hours)	1,000	1,440	0	0	-440	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 440 hours and an increase of 17 responses. Factors contributing to the revision of the burden estimate include the addition of the two new accessory classification pathways crated by FDARA and the removal of redundant burden described earlier in this document.

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Annual Cost to Federal Government: $9,055,218

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/21/2019

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